Generic Chiral Application Center
An increasing number of generic chiral pharmaceuticals are being developed by companies across the world. To keep pace with this increase in the marketplace, analytical chemists (who develop enantiomeric separation methods to ensure the quality of chiral generic drugs) are often faced with many questions and concerns.
- Will my existing column set be sufficient to support the requirements for developing new analytical methods?
- Do I need to add more chiral columns to the existing column set?
- Is a vendor-provided analytical method reproducible?
- If the analytical method is not reproducible, how can I develop a reproducible method?
Daicel has been assisting generic pharmaceutical companies with the development of enantiomeric separations for several years. To utilize Daicel’s extensive experience in developing chiral analytical methods, we have formed a Generic Chiral Application Center at Daicel Chiral Technologies India. This resource is now available to support all generic pharmaceutical manufacturers.
Our support program includes:
The Generic Chiral Application Center has developed numerous chiral methods for generic drugs and lists them for you in a searchable database.
APPLICATION NOTE OF THE MONTH
SEPARATION OF REMDESIVIR KEY STARTING MATERIALS
With the current focus of a COVID-19 treatments aimed at the broad spectrum anti-viral medication Remdesivir, the synthesis and purification of the key starting materials is more critical now than ever. Remdesivir is produced via the coupling of two important scaffolds: a nucleoside and a phosphoramidite. DAICEL has developed analytical methods for the purity assessment of both scaffolds: one for the analysis of the starting nucleoside, both triol and tri o-benzylated, and two for the pentafluoro- and 4-nitrobenzyl- variants of the phosphoramidite.
PHARMACOPEIA METHOD VERIFICATIONS
- Method verification of generic drugs listed in various Pharmacopeia including USP / EP / BP / JP / IP.
- Review and confirm the Pharmacopeia-listed methods and keep chromatograms on file including the complete analytical details. In case modifications are required, the changes to the Pharmacopeia methods will be highlighted. This data will be provided to customers upon request.
- Provide alternate chiral analytical method against prevalent methods having columns with short life (Eg. Chiral Separation using Cyclodextrin products).
- Provide alternative chiral HPLC analytical methods against GC chiral methods.
- Proactively verify the methods published by Pharmacopeia for public comment.
CHIRAL HPLC METHOD DEVELOPMENT FOR
ANALYSES OF GENERIC DRUGS
A key requirement for generic drug quality is the availability of a validated chiral analytical method, which provides analyses of impurities and meeting LOD, LOQ & peak symmetry requirements.
We will address the various stages of chiral method development for generic drugs:
- Chiral HPLC methods for Key Starting Materials
- Chiral HPLC methods for Intermediates
- Chiral HPLC methods for API’s (Drug Substances)
- Chiral HPLC Methods for Formulations (Drug Products)
CHIRAL LC/MS-COMPATIBLE METHOD
DEVELOPMENT FOR GENERIC DRUGS
A manufacturer of chiral generic drugs is required to prove bio-equivalence, through clinical studies of chiral generic drugs. This encompasses exhaustive analyses using LC/MS methods. Chiral Technologies supports our customers by developing highly productive Chiral Analytical methods that are compatible with the LC/MS mobile phase requirements.
Contact the Generic Chiral Application Center for help with your next Generic Drug Method Development firstname.lastname@example.org